EUCTR2013-002707-33-BG进行中（未招募）1 期
A Phase 3, Randomized, Double-blind Active-controlled Study Evaluating Momelotinib vs. Ruxolitinib in Subjects with Primary Myelofibrosis (PMF) or Post-Polycythemia Vera or Post- Essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 420
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Age = 18 years old
- •-Palpable splenomegaly at least 5 cm below left costal margin
- •-Confirmed diagnosis of PMF or post-PV/ET MF in accordance with the World Health Organization (WHO) or International Working Group for Myelofibrosis Research and Treatment (IWG MRT) criteria
- •-Requires myelofibrosis therapy, in the opinion of the investigator
- •-High risk OR intermediate-2 risk as defined by the International Prognostic Scoring System (IPSS) for Primary Myelofibrosis; OR intermediate-1 risk as defined by IPSS and associated with symptomatic splenomegaly, hepatomegaly, anemia (Hgb < 10.0 g/dL), and/or unresponsive to available therapy
- •-Acceptable laboratory assessments obtained within 14 days prior to the first dose of IP:
- •Absolute neutrophil count (ANC) = 0.75 x 10^9/L in the absence of growth factor in the prior 7 days
- •Platelet Count = 50 x 10^9/L ( =100 x 10^9/L if AST/SGOT or ALT/SGPT = 2 x ULN) in the absence of platelet transfusion(s) or thrombopoietin mimetics in the prior 7 days
- •Peripheral blood blast count < 10%
- •AST/SGOT and ALT/SGPT = 3 x ULN (=5 x ULN if liver is involved by extramedullary hematopoiesis as judged by the investigator or if related to iron chelator therapy that was started within the prior 60 days)
- •Calculated creatinine clearance of = 45 mL/min
- •Direct bilirubin = 2.0 x ULN
- •-Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •-Life expectancy of > 24 weeks
- •-Negative serum pregnancy test for female subjects (unless surgically sterile or greater than 2 years post-menopausal)
- •-Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
- •-Females who are nursing must agree to discontinue nursing before the first dose of IP
- •-Able to understand and willing to sign the informed consent form
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 147
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 273
排除标准
- •-Prior splenectomy
- •-Splenic irradiation within 3 months prior to the first dose of IP
- •-Eligible for allogeneic bone marrow or stem cell transplantation
- •-Uncontrolled intercurrent illness including, but not limited to: active uncontrolled infection (subjects receiving outpatient antibacterial and/or antiviral treatments for infection that is under control or as infection prophylaxis may be included in the study); active or chronic bleeding within 4 weeks prior to the first dose of IP; symptomatic congestive heart failure; unstable angina pectoris; uncontrolled cardiac arrhythmia; or psychiatric illness/social situation that would limit compliance with study requirements as judged by treating physician
- •-QTc interval > 450 msec, unless attributed to bundle branch block
- •-History of a concurrent or second malignancy except for adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for = 1 year prior to randomization, adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for = 5 years
- •-Known positive status for human immunodeficiency virus (HIV)
- •-Chronic active or acute viral hepatitis A, B, or C infection (testing required for hepatitis B and C), or hepatitis B or C carrier
- •-Prior use of a JAK1 or JAK2 inhibitor
- •-Use of strong CYP3A4 inhibitors or strong CYP3A4 inducers or dual inhibitors of CYP3A4 and CYP2C9 within 1 week prior to the first dose of IP
- •-Use of chemotherapy, immunomodulating therapy, biologic therapy, radiation therapy, or investigational therapy within 4 weeks of the first dose of IP
- •-Changes to dose of iron chelator therapy within 14 days of the first dose of IP
- •-Unresolved non-hematologic toxicities from prior therapies that are > CTCAE Grade 1
- •-Presence of peripheral neuropathy = CTCAE Grade 2
- •-Unwilling or unable to undergo a MRI or CT Scan
- •-Known hypersensitivity to the IPs, the metabolites, or formulation excipients
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